Royalty Pharma and Agios Pharmaceuticals Enter Into Vorasidenib Royalty Agreement for $905 Million
Royalty Pharma announced a $905 million agreement with Agios Pharmaceuticals to acquire future royalties on Servier’s vorasidenib, contingent on FDA approval. Vorasidenib, a targeted therapy for IDH-mutant glioma, has shown unprecedented efficacy and tolerability in Phase 3 trials and received priority review with a PDUFA date of August 20, 2024.
The drug is projected to achieve over $1 billion in annual peak sales in the U.S., potentially generating more than $150 million in annual royalties for Royalty Pharma. If approved, royalties may continue through 2038.
An investor call is scheduled for today, May 28, to discuss the deal.
- Royalty Pharma's $905 million investment in vorasidenib could yield significant returns.
- Vorasidenib is projected to generate over $1 billion in annual peak sales in the U.S.
- Potential for over $150 million in annual royalties for Royalty Pharma.
- Vorasidenib demonstrated unprecedented efficacy and tolerability in Phase 3 trials.
- FDA granted priority review for vorasidenib, with a PDUFA date of August 20, 2024.
- If approved, royalty revenue may continue through 2038.
- The $905 million payment is contingent on FDA approval, adding financial risk.
- No guarantee of FDA approval or market success for vorasidenib.
- High dependency on a single drug for significant financial returns.
Insights
The acquisition of a royalty interest in vorasidenib for
Short-Term: The financial impact hinges on regulatory approval, making it a high-risk, high-reward scenario. Positive news could significantly boost Royalty Pharma's stock.
Long-Term: Successful market penetration of vorasidenib would provide a steady revenue stream through 2038, enhancing Royalty Pharma's financial stability.
Vorasidenib represents a potential breakthrough in the treatment of IDH-mutant gliomas, a type of brain tumor with limited existing therapies. Its mechanism as a dual inhibitor of mutant IDH1 and IDH2 enzymes is significant, as these mutations play a critical role in the growth of glioma cells. The pivotal Phase 3 INDIGO trial demonstrated a meaningful extension of progression-free survival, which is a substantial clinical benefit. The FDA's priority review and Breakthrough Therapy Designation underscore the drug's potential impact on patient care.
Short-Term: FDA approval could immediately improve treatment options for patients with IDH-mutant gliomas, providing hope for better management of this challenging condition.
Long-Term: If vorasidenib proves effective in broader clinical practice, it could set a new standard in glioma treatment, potentially spurring further innovations in oncology therapies.
The market for IDH-mutant gliomas, while relatively small with an incidence of approximately 1,500 patients per year in the U.S., represents a niche but critical segment. Royalty Pharma's projection of over
Short-Term: The anticipation around the PDUFA date will likely drive market interest and stock volatility. Positive FDA feedback could result in rapid stock price appreciation.
Long-Term: Sustained sales will depend on clinical efficacy, safety profile and the ability to navigate the competitive and regulatory landscape effectively.
- Vorasidenib, if approved, would be the first targeted therapy in IDH-mutant glioma, a progressive and incurable brain tumor
- Pivotal Phase 3 clinical study of vorasidenib demonstrated unprecedented efficacy and tolerability; vorasidenib granted priority review with PDUFA date of August 20, 2024
- Royalty Pharma projects greater than
$1 billion in peak sales annually for vorasidenib in the U.S.; potential to generate royalties exceeding$150 million annually - Royalty Pharma to host investor call today, Tuesday, May 28 at 8:30am EDT
NEW YORK, May 28, 2024 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today announced that it has acquired an interest in Agios Pharmaceuticals’ royalty on Servier’s vorasidenib for
“We are excited to acquire royalties on vorasidenib, which if approved, would be the first targeted therapy for patients with IDH-mutant glioma,” said Pablo Legorreta, founder and Chief Executive Officer of Royalty Pharma. “Innovation has been lacking in glioma treatment for over two decades, and we believe vorasidenib, which demonstrated unprecedented efficacy with a well-tolerated safety profile in its pivotal clinical study, is a potentially transformative therapy. We look forward to its upcoming PDUFA date and are excited for IDH-mutant diffuse glioma patients to potentially have a new treatment option.”
Vorasidenib is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma. Low grade IDH-mutant diffuse gliomas have an incidence of approximately 1,500 patients per year and a prevalence of approximately 10,000 in the U.S. according to Royalty Pharma estimates. The pivotal Phase 3 INDIGO clinical trial for vorasidenib met its primary endpoint with a clinically meaningful extension of progression-free survival and the key secondary endpoint of time to next intervention. Vorasidenib was granted Breakthrough Therapy Designation by the FDA, and it received priority review with a Prescription Drug User Fee Act action (PDUFA) date of August 20, 2024.
Under the terms of the agreement, Royalty Pharma will pay Agios
Royalty Pharma projects greater than
Conference Call Information
Royalty Pharma will host a conference call and simultaneous webcast to discuss the transaction today, Tuesday, May 28th at 8:30 a.m. Eastern Time. Please visit the “Investors” page of the company’s website at https://www.royaltypharma.com/investors/events/ to obtain conference call information and to view the live webcast. A replay of the conference call and webcast will be archived on the company’s website for at least 30 days.
Advisors
Goodwin Procter LLP and Fenwick & West LLP acted as legal advisors to Royalty Pharma.
About Royalty Pharma plc
Founded in 1996, Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry, collaborating with innovators from academic institutions, research hospitals and non-profits through small and mid-cap biotechnology companies to leading global pharmaceutical companies. Royalty Pharma has assembled a portfolio of royalties which entitles it to payments based directly on the top-line sales of many of the industry’s leading therapies. Royalty Pharma funds innovation in the biopharmaceutical industry both directly and indirectly - directly when it partners with companies to co-fund late-stage clinical trials and new product launches in exchange for future royalties, and indirectly when it acquires existing royalties from the original innovators. Royalty Pharma’s current portfolio includes royalties on more than 35 commercial products, including Vertex’s Trikafta, Kalydeco, Orkambi and Symdeko, Biogen’s Tysabri, AbbVie and Johnson & Johnson’s Imbruvica, Astellas and Pfizer’s Xtandi, GSK’s Trelegy, Novartis’ Promacta, Pfizer’s Nurtec ODT, Johnson & Johnson’s Tremfya, Roche’s Evrysdi, Gilead’s Trodelvy, and 17 development-stage product candidates.
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FAQ
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